Precision roller clamp assembly

ABSTRACT

A roller clamp assembly for adjusting the fluid flow rate in a flexible infusion tube is provided. The roller clamp assembly includes a housing to receive the flexible tube, a plate slideably engaged with the housing and configured to rapidly compress the flexible tube to provide a coarse fluid flow adjustment, and a roller wheel moveable engaged with the housing and configured to provide a gradual fluid flow adjustment. The plate may be a slide plate received by grooves in an exterior wall of the housing, where the plate moves orthogonally to the flexible tube, or the plate may be a shim plate that moves along an interior wall of the housing in parallel to the flexible tube. Infusion sets and methods of adjusting fluid flow rates are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/572,373, entitled “PRECISION ROLLER CLAMP,” filed on Sep. 16, 2019,the entirety of which is incorporated herein by reference.

TECHNICAL FIELD

The present disclosure generally relates to a gravity intravenous (IV)set or infusion pump flow control device, and in particular a precisionroller clamp assembly.

BACKGROUND

Flow controllers in the form of roller clamps are used in the medicalfield for intravenous (IV) applications. Typical roller clamps control aflow rate through an IV tube by clamping the tube in between a rollerwheel and a housing. This approach, for one, provides a limited range offlow rate control because the roller wheel is essentially too sensitivein that a small movement of the roller wheel or dimension change causesa large change in flow rate of the fluid through the tube. Thus, therelatively course flow rate change provided by a typical roller clampmakes it difficult to provide precise flow control.

Also, typical roller clamps have flow rate drifting issues based onslippage of the roller wheel, such as when fluid pressure in the tubecauses the roller wheel to roll back from the adjusted position.Further, typical roller clamps are sized for a specific IV set tubedimension, which requires having different sized roller clamps for usewith various IV set tube dimensions.

Thus, it is desirable to provide a precision roller wheel assembly thatworks with multiple IV tube sizes, provides quick course flow rateadjustments and fine flow rate adjustments, and eliminates or minimizesroller wheel slippage.

SUMMARY

One or more embodiments provide a roller clamp assembly. The rollerclamp assembly includes a housing configured to receive a flexible tube.The housing includes two opposing side walls, a front wall disposed atone end of the side walls and a guide wall disposed between the sidewalls. The roller clamp assembly also includes a roller wheel movablydisposed in the housing, the roller wheel configured to move along alongitudinal axis of the housing, wherein spacing between the guide walland the roller wheel decreases over a length of the guide wall. Theroller clamp assembly further includes a plate configured to slideablyengage with a portion of the housing. The plate includes a grip memberand a tube engagement member configured to compress the flexible tube avarying amount as the plate is moved in relation to the housing.

One or more embodiments provide an infusion set including an infusioncomponent, a flexible tube and a roller clamp assembly. The roller clampassembly includes a housing configured to receive a flexible tube. Thehousing includes two opposing side walls, a front wall disposed at oneend of the side walls and a guide wall disposed between the side walls.The roller clamp assembly also includes a roller wheel movably disposedin the housing, the roller wheel configured to move along a longitudinalaxis of the housing, wherein spacing between the guide wall and theroller wheel decreases over a length of the guide wall. The roller clampassembly further includes a plate configured to slideably engage with aportion of the housing. The plate includes a grip member and a tubeengagement member configured to compress the flexible tube a varyingamount as the plate is moved in relation to the housing. An increasedimpingement of the roller wheel on the flexible tube is configured toreduce a fluid flow rate through the flexible tube.

One or more embodiments provide a method of adjusting a fluid flow ratethrough a flexible tube coupled to a fluid source. The method includesinserting the flexible tube through a roller clamp assembly comprising ahousing configured to receive a flexible tube, the housing including twoopposing side walls, a front wall disposed at one end of the side wallsand a guide wall disposed between the side walls, a roller wheel movablydisposed in the housing, the roller wheel configured to move along alongitudinal axis of the housing, wherein spacing between the guide walland the roller wheel decreases over a length of the guide wall, and aplate configured to slideably engage with a portion of the housing, theplate including a grip member and a tube engagement member configured tocompress the flexible tube a varying amount as the plate is moved inrelation to the housing. The method also includes sliding the platerelative to the housing to compress the flexible tubing with a firstimpingement to produce a coarse adjustment that causes a rapid decreasein the fluid flow rate through the flexible tube. The method furtherincludes rolling the roller wheel relative to the housing to compressthe flexible tubing with a second impingement to produce a fineadjustment that causes a further gradual decrease in the fluid flow ratethrough the flexible tube.

The foregoing and other features, aspects and advantages of thedisclosed embodiments will become more apparent from the followingdetailed description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosure andtogether with the description serve to explain the principles of thedisclosure.

FIG. 1 depicts a perspective view of an example infusion set having atypical roller clamp.

FIG. 2 depicts a cross-section side view of the roller clamp of FIG. 1 .

FIG. 3 depicts a perspective view of a precision roller clamp assembly.

FIG. 4 depicts a top plan view of the precision roller clamp assembly ofFIG. 3 .

FIG. 5 depicts a front elevation view of the precision roller clampassembly of FIG. 3 .

FIG. 6 depicts a perspective view of a slide plate from the precisionroller clamp assembly of FIG. 3 .

FIG. 7 depicts a cross-section perspective view of the precision rollerclamp assembly of FIG. 3 .

FIG. 8 depicts a perspective view of a precision roller clamp assembly.

FIG. 9 depicts a perspective view of a slide plate from the precisionroller clamp assembly of FIG. 8 .

FIG. 10 depicts a perspective view of a precision roller clamp assembly.

FIG. 11 depicts a perspective view of a slide plate from the precisionroller clamp assembly of FIG. 10 .

FIG. 12 depicts a perspective view of a precision roller clamp assembly.

FIG. 13 depicts a perspective view of a housing of the precision rollerclamp assembly of FIG. 12 .

FIG. 14 depicts a side view of the housing of FIG. 13 .

FIG. 15 depicts a perspective view of a shim plate of the precisionroller clamp assembly of FIG. 12 .

FIG. 16 depicts a method of using a precision roller clamp assembly.

DETAILED DESCRIPTION

The detailed description set forth below describes variousconfigurations of the subject technology and is not intended torepresent the only configurations in which the subject technology may bepracticed. The detailed description includes specific details for thepurpose of providing a thorough understanding of the subject technology.Accordingly, dimensions are provided in regard to certain aspects asnon-limiting examples. However, it will be apparent to those skilled inthe art that the subject technology may be practiced without thesespecific details. In some instances, well-known structures andcomponents are shown in block diagram form in order to avoid obscuringthe concepts of the subject technology.

It is to be understood that the present disclosure includes examples ofthe subject technology and does not limit the scope of the appendedclaims. Various aspects of the subject technology will now be disclosedaccording to particular but non-limiting examples. Various embodimentsdescribed in the present disclosure may be carried out in different waysand variations, and in accordance with a desired application orimplementation.

The present disclosure relates to a roller clamp and in particular to aroller clamp for use in gravity infusion. The roller clamp regulates theflow rate of a medical fluid (for example a solution of a drug to beadministered to a patient, or blood) flowing through a tube. Typically,a standard infusion set is used to infuse the fluid. An example of astandard infusion set is shown in FIG. 1 .

The infusion set includes a piercing spike 20 which may either be asharp spike for piercing rubber stoppers or rounded and blunt forinsertion into a bag. The spike contains one channel for fluid andoptionally a second channel for venting. A vent 21 is usually present inthe vicinity of the piercing spike to allow air to flow into the dropchamber 22. The vent 21 may be provided with a bacterial filter toprevent bacteria from entering the equipment.

The drop chamber 22 has a drop generator 23 at the top of the dropchamber 22 that produces drops of a certain size. Drops from the dropgenerator 23 fall into the drop chamber 22 such that the drop chamber 22is partially filled with liquid. This prevents air bubbles from enteringthe connector tube 24, which would be harmful to a patient. A particlefilter may be provided at the lower aperture of the drop chamber 22.

The connector tube 24 connects the drop chamber 22 with the patient. Theconnector tube 24 is usually around 150 cm long and can be manufacturedfrom PVC. The tube 24 is shown shortened in FIG. 1 for clarity. Theconnector tube 24 typically has a continuous diameter throughout thelength of the tube.

At the end of the connector tube 24 is a Luer fitting 25 which isstandardized for connection to all other pieces of apparatus having astandard Luer cone. The person skilled in the art will appreciate thatthe Luer fitting 25 can be fitted to a hypodermic needle (not shown) forinfusing the medical fluid into the circulatory system of a patient(e.g., into a vein).

Between the drop chamber 22 and the Luer fitting 25 and engaging withthe connector tube 24, is a roller clamp 26. The present disclosure isconcerned with an improved roller clamp assembly, but a typical rollerclamp 26 as known in the art will now be described for backgroundinformation.

The roller clamp 26 illustrated in FIG. 2 has two opposing side walls 27having a pair of guide grooves 30 that are aligned with each other andface each other. A flow-regulating roller 28 is provided havingaxially-projecting shafts 29 protruding from the centers of each side ofthe roller 28. The roller 28 is shown in outline for clarity. The shafts29 of the roller 28 are captured by and seated in the guide grooves 30so that the roller 28 can move up and down the guide grooves 30 asindicated by the arrows in FIG. 2 .

The entire roller clamp 26 has four walls (see FIG. 1 ) in an open-endedboxlike construction and is dimensioned and configured to receive theconnector tube 24. In use, the tube 24 passes through the roller clamp26, between the two opposing side walls 27, the roller 28 and a guidewall 31 that is opposed to the roller 28.

In the roller clamp 26, the surface of the guide wall 31 converges alongits length toward the position of the guide grooves 30 in the downwarddirection of the guide grooves 30 (e.g., in the direction of the arrowsin FIG. 2 ). This tends to urge the connector tube 24 within the rollerclamp 26 toward the guide grooves 30 and thus toward roller 28.

Thus, rolling the roller 28 downwardly along the guide grooves 30 in thedirection of the gradually closer guide wall 31 in the direction of thearrows causes the roller 28 to impinge against the connector tube 24. Asthe roller 28 impinges on the tube 24, the tube 24 becomes squeezed, asit is a flexible material such as PVC, and the lumen of the infusiontube 24 therefore becomes smaller. In this way, by narrowing of thelumen, the flow rate of liquid passing through the connector tube 24 canbe regulated.

Thus, the roller clamp 26 controls the flow rate through the infusiontube 24 by clamping the infusion tube 24 between the roller 28 and theguide wall 31. As discussed above, this provides for a course flow ratechange because a small movement of the roller 28 causes a large changein the flow rate of the fluid through the tube 24. Also, the force ofthe fluid in the tube 24 exerts a biasing force against the roller 28,which often leads to slippage of the roller 28 (e.g., the roller 28rolls back) from the adjusted position. In addition, the roller 28 needsto be sized for the tube 24 dimensions, so if a different size (e.g.,diameter) tubing is used, a different size roller must then be used aswell.

With reference to FIGS. 3-7 , a multistage precision roller clampassembly 100 is shown. The roller clamp assembly 100 has a housing 105having an open-ended boxlike construction and is dimensioned andconfigured to receive tubing, such as connector tube 24. Two opposingside walls 110 each have a guide groove 120 that are aligned with eachother and face each other. A flow-regulating roller 130 is providedhaving axially-projecting shafts 132 protruding from the centers of eachside of the roller 130. The shafts 132 of the roller 130 are seated inthe guide grooves 120 so that the roller 130 can move up and down theguide grooves 120. A guide wall 112 is opposed to the roller 130 and thesurface of the guide wall 112 converges along its length toward theposition of the guide grooves 120.

In use, the tube 24 passes through the roller clamp assembly 100,between the two opposing side walls 110, the roller 130 and the guidewall 112 that is opposed to the roller 130. Rolling the roller 130downwardly along the guide grooves 120 in the direction of the graduallycloser guide wall 112 causes the roller 130 to impinge against the tube24. As the roller 130 impinges on the tube 24, the tube 24 becomessqueezed, as it is a flexible material such as PVC, and the lumen of theinfusion tube 24 therefore becomes smaller. In this way, by narrowing ofthe lumen, the flow rate of liquid passing through the connector tube 24can be regulated.

However, regulation of the fluid flow rate by adjusting the roller 130may provide a large change in flow rate for a small movement of theroller 130. For example, with the roller 130 in a wide open positionwhere the roller 130 does not impinge on the tube 24, a fluid flow ratemay be anywhere from 2,000 to 8,000 milliliters per hour (ml/hr). Thisflow rate may be too fast to count drips in a drip chamber (e.g., dropchamber 22) as the maximum flow rate for counting drops may be 250ml/hr. Thus, for flow rates above 250 ml/hr, the roller 130 may havedifficulty precisely controlling or adjusting the flow rate.

Accordingly, the precision roller clamp assembly 100 also includes afront wall 140 disposed at one end of the side walls 110. The front wall140 includes grooves 142 configured to receive a slide plate 150. Theslide plate 150 includes a plate wall 151, a grip member 152 and a tubeengagement channel 154. The grip member 152 may protrude out (e.g.,project orthogonally) from the plate wall 151 and provide a surface thatmay be pushed or pulled to slidably move the slide plate 150 within thegrooves 142, the slide plate 150 being movable towards or away from thetube 24 disposed through the roller clamp assembly 100.

The tube engagement channel 154 may be configured to engage with thetube 24 and provide coarse control (e.g., rapid change) of the fluidflow rate through the tube 24. For example, as shown in FIGS. 5 and 6 ,the tube engagement channel 154 may have a first portion 154 a having auniform width, a second portion 154 b having a linearly decreasingwidth, and a third portion 154 c having a uniform width narrower thanthe width of the first portion. The different widths of the first,second and third portions 154 a, 154 b, 154 c, allows the tubeengagement channel 154 to engage with tube 24 of various sizes (e.g.,diameters), for example. As another example, the different widths of thefirst, second and third portions 154 a, 154 b, 154 c, allows the tubeengagement channel 154 to provide different levels of compression orimpingement on the same sized tube 24 based on how fare the slide plate150 is moved towards the tube 24. The tube engagement channel 154 may bedisposed centrally in a leading edge 156 of the slide plate 150, and thetube engagement channel 154 may have a steeple shape, as shown in FIG. 5.

For example, the slide plate 150 may be moved from a wide open position(e.g., not impinging upon tube 24) to an engaged position in which thetube 24 is engaged within the tube engagement channel 154. Thus, theslide plate 150 provides a coarse control where the fluid flow rate of2,000 to 8,000 ml/hr in the wide open position may be quickly adjustedto a fluid flow rate of 250 ml/hr when the slide plate 150 is moved intothe engaged position. As another example, the fluid flow rate may bequickly adjusted to a fully blocked flow rate of 0 ml/hr (e.g., quickocclusion), or any other desired fluid flow rate between 250 ml/hr and 0ml/hr (e.g., 50 ml/hr, 125 ml/hr), when the slide plate 150 is movedinto the fully engaged position. Thus, the slide plate 150 may beconfigured as a substantially binary flow switch (e.g., on/off switch),for example, where the flow rate is either wide open or adjusted down toa specific flow rate such as 250 ml/hr, or even to a fully blocked flowrate of 0 ml/hr.

The combination of the slide plate 150 and the roller 130 provides forboth coarse and fine control of the fluid flow in tube 24. For example,with both the slide plate 150 and the roller 130 in their respectivewide open positions, the slide plate 150 may be moved to the engagedposition, thus quickly adjusting the fluid flow rate of 2,000 to 8,000ml/hr down to 250 ml/hr, or even to a fully blocked flow (e.g., quickocclusion). For an adjusted fluid flow rate that is not fully occluded,the roller 130 may then be moved within the housing 105 to increasinglyimpinge further upon tube 24 in a more gradual manner, providing a finerand more precise adjustment of the fluid flow rate. For example, theroller 130 may be moved from its wide open position near one end of thehousing 105 in which the fluid flow rate is 250 ml/hr to a fullyimpinging position towards the opposite end of the housing 105 in whichthe fluid flow rate is 0 ml/hr (e.g., fully blocked). The length oftravel of the roller 130 between the two positions allows for granularand precise changes in fluid flow rate via the roller 130 with the slideplate 150 engaged. For an adjusted fluid flow rate that is fullyoccluded after full engagement of the slide plate 150, movement of theroller 130 may not be needed nor provide further flow rate adjustment.

The precision roller clamp assembly 100 may be configured so that theslide plate 150 is automatically moved to the fully engaged positionwhen the roller 130 is moved from its wide open position to an initialcontrol position (e.g., where the roller 130 initially begins to impingethe tube 24). In this manner, a user (e.g., healthcare provider,patient) or an adjustment device only needs to touch and adjust theroller 130.

With reference to FIGS. 8 and 9 , a multistage precision roller clampassembly 200 is shown. Many of the features of roller clamp assembly 200are the same as that of roller clamp assembly 100 and the same referencenumbers are used for those features. The roller clamp assembly 200 has ahousing 105 having an open-ended boxlike construction and is dimensionedand configured to receive tubing, such as connector tube 24. Twoopposing side walls 110 each have a guide groove 120 that are alignedwith each other and face each other. A flow-regulating roller 130 isprovided having axially-projecting shafts 132 protruding from thecenters of each side of the roller 130. The shafts 132 of the roller 130are seated in the guide grooves 120 so that the roller 130 can move upand down the guide grooves 120. A guide wall 112 is opposed to theroller 130 and the surface of the guide wall 112 converges along itslength toward the position of the guide grooves 120.

The roller clamp assembly 200 also includes a front wall 140 disposed atone end of the side walls 110. The front wall 140 includes grooves 142configured to receive a slide plate 250. The slide plate 250 includes aplate wall 251, a grip member 252 and a tube engagement channel 254. Thegrip member 252 may protrude out (e.g., project orthogonally) from theplate wall 251 and provide a surface that may be pushed or pulled toslidably move the slide plate 250 within the grooves 142, the slideplate 250 being movable towards or away from the tube 24 disposedthrough the roller clamp assembly 200.

The tube engagement channel 254 may be configured to engage with thetube 24 and provide coarse control (e.g., rapid change) of the fluidflow rate through the tube 24. For example, as shown in FIG. 9 , thetube engagement channel 254 may have a first portion 254 a having alinearly decreasing width and a second portion 254 b having a uniformwidth. The varying width of the first portion 254 a allows the tubeengagement channel 254 to engage with tube 24 of various sizes (e.g.,diameters), for example. As another example, the varying width of thefirst portion 254 a allows the tube engagement channel 254 to providedifferent levels of compression or impingement on the same sized tube 24based on how far the slide plate 250 is moved towards the tube 24. Thetube engagement channel 254 may be disposed centrally in the slide plate250 and linearly narrow inwards from a leading edge 256 of the slideplate 250. Thus, the tube engagement channel 254 may have asubstantially triangular shape, as shown in FIG. 9 .

For example, the slide plate 250 may be moved from a wide open position(e.g., not impinging upon tube 24) to an initial engaged position inwhich the tube 24 is initially engaged but not impinged by the tubeengagement channel 254. From the initial engaged position, the slideplate 250 may be moved further towards the tube 24 such that the tube 24is engaged by narrower portions of the tube engagement channel 254,which impinges the tube 24 to a greater degree and causes a reduction inthe fluid flow rate. The slide plate 250 may have a fully engagedposition in which the tube 24 is engaged by narrow most portions of thetube engagement channel 254. Thus, the slide plate 250 provides a coarsecontrol where, for example, the fluid flow rate of 2,000 to 8,000 ml/hrin the wide open position may be quickly adjusted to a fluid flow rateof 250 ml/hr when the slide plate 250 is moved into the fully engagedposition. As another example, the fluid flow rate may be quicklyadjusted to a fully blocked flow rate of 0 ml/hr (e.g., quickocclusion), or any other desired fluid flow rate between 250 ml/hr and 0ml/hr (e.g., 50 ml/hr, 125 ml/hr), when the slide plate 250 is movedinto the fully engaged position. Positioning the slide plate 250 betweenthe wide open position and the fully engaged position will result in thefluid flow rate being between the wide open rate and the fully engagedrate. Thus, the slide plate 250 may be configured as a linearlyadjusting flow switch (e.g., dimmer switch), for example, where the flowrate linearly adjusts down from a wide open flow rate to a final coarseflow rate (e.g., 250 ml/hr), or even to a fully blocked flow rate (e.g.,0 ml/hr).

The combination of the slide plate 250 and the roller 130 provides forboth coarse and fine control of the fluid flow in tube 24. For example,with both the slide plate 250 and the roller 130 in their respectivewide open positions, the slide plate 250 may be moved towards or to thefully engaged position, thus quickly adjusting the fluid flow rateanywhere from the wide open rate of 2,000 to 8,000 ml/hr down to 250ml/hr, or even to a fully blocked flow (e.g., quick occlusion). For anadjusted fluid flow rate that is not fully occluded, the roller 130 maythen be moved within the housing 105 to increasingly impinge furtherupon tube 24 in a more gradual manner, providing a finer and moreprecise adjustment of the fluid flow rate. For example, the roller 130may be moved from its wide open position near one end of the housing 105in which the fluid flow rate is 250 ml/hr to a fully impinging positiontowards the opposite end of the housing 105 in which the fluid flow rateis 0 ml/hr (e.g., fully blocked). The length of travel of the roller 130between the two positions allows for granular and precise changes influid flow rate via the roller 130 with the slide plate 250 partially orfully engaged. For an adjusted fluid flow rate that is fully occludedafter full engagement of the slide plate 250, movement of the roller 130may not be needed nor provide further flow rate adjustment.

The precision roller clamp assembly 200 may be configured so that theslide plate 250 is automatically moved to a particular engaged positionwhen the roller 130 is moved from its wide open position to an initialcontrol position (e.g., where the roller 130 initially begins to impingethe tube 24). In this manner, a user (e.g., healthcare provider,patient) or an adjustment device only needs to touch and adjust theroller 130.

With reference to FIGS. 10 and 11 , a multistage precision roller clampassembly 300 is shown. Many of the features of roller clamp assembly 300are the same as that of roller clamp assembly 100 and the same referencenumbers are used for those features. The roller clamp assembly 300 has ahousing 105 having an open-ended boxlike construction and is dimensionedand configured to receive tubing, such as connector tube 24. Twoopposing side walls 110 each have a guide groove 120 that are alignedwith each other and face each other. A flow-regulating roller 130 isprovided having axially-projecting shafts 132 protruding from thecenters of each side of the roller 130. The shafts 132 of the roller 130are seated in the guide grooves 120 so that the roller 130 can move upand down the guide grooves 120. A guide wall 112 is opposed to theroller 130 and the surface of the guide wall 112 converges along itslength toward the position of the guide grooves 120.

The roller clamp assembly 300 also includes a front wall 140 disposed atone end of the side walls 110. The front wall 140 includes grooves 142configured to receive a slide plate 350. The slide plate 350 includes aplate wall 351, a grip member 352 and a tube engagement channel 354. Thegrip member 352 may protrude out (e.g., project orthogonally) from theplate wall 351 and provide a surface that may be pushed or pulled toslidably move the slide plate 350 within the grooves 142, the slideplate 350 being movable towards or away from the tube 24 disposedthrough the roller clamp assembly 300.

The tube engagement channel 354 may be configured to engage with thetube 24 and provide coarse control (e.g., rapid change) of the fluidflow rate through the tube 24. For example, as shown in FIG. 11 , thetube engagement channel 354 may have a first portion 354 a having alinearly decreasing width and a second portion 354 b having a uniformwidth. The varying width of the first portion 354 a allows the tubeengagement channel 354 to engage with tube 24 of various sizes (e.g.,diameters), for example. As another example, the varying width of thefirst portion 354 a allows the tube engagement channel 354 to providedifferent levels of compression or impingement on the same sized tube 24based on how far the slide plate 350 is moved towards the tube 24. Thetube engagement channel 354 may be disposed offset to the center of theslide plate 350 (e.g., towards one side). The tube engagement channel354 may have one straight side 353 and another angled side 355 having aportion that linearly narrows inwards from a leading edge 356 of theslide plate 350. Thus, the tube engagement channel 354 may have a meldedrectangular/angular shape, as shown in FIG. 11 .

For example, the slide plate 350 may be moved from a wide open position(e.g., not impinging upon tube 24) to an initial engaged position inwhich the tube 24 is initially engaged but not impinged by the tubeengagement channel 354. From the initial engaged position, the slideplate 350 may be moved further towards the tube 24 such that the tube 24is engaged by narrower portions of the tube engagement channel 354,which impinges the tube 24 to a greater degree and causes a reduction inthe fluid flow rate. The slide plate 350 may have a fully engagedposition in which the tube 24 is engaged by narrow most portions of thetube engagement channel 354. Thus, the slide plate 350 provides a coarsecontrol where, for example, the fluid flow rate of 2,000 to 8,000 ml/hrin the wide open position may be quickly adjusted to a fluid flow rateof 250 ml/hr when the slide plate 350 is moved into the fully engagedposition. As another example, the fluid flow rate may be quicklyadjusted to a fully blocked flow rate of 0 ml/hr (e.g., quickocclusion), or any other desired fluid flow rate between 250 ml/hr and 0ml/hr (e.g., 50 ml/hr, 125 ml/hr), when the slide plate 350 is movedinto the fully engaged position. Positioning the slide plate 350 betweenthe wide open position and the fully engaged position will result in thefluid flow rate being between the wide open rate and the fully engagedrate. Thus, the slide plate 350 may be configured as a linearlyadjusting flow switch (e.g., dimmer switch), for example, where the flowrate linearly adjusts down from a wide open flow rate to a final coarseflow rate (e.g., 250 ml/hr), or even to a fully blocked flow rate (e.g.,0 ml/hr).

The combination of the slide plate 350 and the roller 130 provides forboth coarse and fine control of the fluid flow in tube 24. For example,with both the slide plate 350 and the roller 130 in their respectivewide open positions, the slide plate 350 may be moved towards or to thefully engaged position, thus quickly adjusting the fluid flow rateanywhere from the wide open rate of 2,000 to 8,000 ml/hr down to 250ml/hr, or even to a fully blocked flow (e.g., quick occlusion). For anadjusted fluid flow rate that is not fully occluded, the roller 130 maythen be moved within the housing 105 to increasingly impinge furtherupon tube 24 in a more gradual manner, providing a finer and moreprecise adjustment of the fluid flow rate. For example, the roller 130may be moved from its wide open position near one end of the housing 105in which the fluid flow rate is 250 ml/hr to a fully impinging positiontowards the opposite end of the housing 105 in which the fluid flow rateis 0 ml/hr (e.g., fully blocked). The length of travel of the roller 130between the two positions allows for granular and precise changes influid flow rate via the roller 130 with the slide plate 350 partially orfully engaged. For an adjusted fluid flow rate that is fully occludedafter full engagement of the slide plate 350, movement of the roller 130may not be needed nor provide further flow rate adjustment.

The precision roller clamp assembly 300 may be configured so that theslide plate 350 is automatically moved to a particular engaged positionwhen the roller 130 is moved from its wide open position to an initialcontrol position (e.g., where the roller 130 initially begins to impingethe tube 24). In this manner, a user (e.g., healthcare provider,patient) or an adjustment device only needs to touch and adjust theroller 130.

With reference to FIGS. 12-15 , a multistage precision roller clampassembly 400 is shown. Some of the features of roller clamp assembly 400are the same as that of roller clamp assembly 100 and the same referencenumbers are used for those features. The roller clamp assembly 400 has ahousing 405 having an open-ended boxlike construction and is dimensionedand configured to receive tubing, such as connector tube 24. Twoopposing side walls 410 each have a guide groove 420 that are alignedwith each other and face each other. A flow-regulating roller 130 isprovided having axially-projecting shafts 132 protruding from thecenters of each side of the roller 130. The shafts 132 of the roller 130are seated in the guide grooves 420 so that the roller 130 can move upand down the guide grooves 420. A guide wall 412 is opposed to theroller 130 and the surface of the guide wall 412 converges along itslength toward the position of the guide grooves 420.

The roller clamp assembly 400 also includes a front wall 440 disposed atone end of the side walls 410. The front wall 440 includes an opening442 configured to receive a shim plate 450. The shim plate 450 includesa plate wall 451, a grip member 452 and a tube engagement wall 454. Thegrip member 452 may extend out (e.g., project linearly) from the platewall 451 and provide a surface that may be pushed or pulled to slidablymove the shim plate 450 back and forth within the housing 405. The shimplate 450 is movable in parallel with the tube 24 disposed through theroller clamp assembly 400, so that the thickness of the tube engagementwall 454 may vary at a particular portion of the tube 24. For example,the tube engagement wall 454 may have a varying thickness with athinnest portion 453 at one end and a thickest portion 455 at the otherend (e.g., a shim). The tube engagement wall 454 may be configured toengage with the tube 24 and provide coarse control (e.g., rapid change)of the fluid flow rate through the tube 24.

For example, the shim plate 450 may be moved from a wide open positionin which the thinnest portion 453 of the tube engagement wall 454 may beengaged with but not impinging upon tube 24, to an engaged position inwhich the thickest portion 455 of the tube engagement wall 454 isengaged with and impinging the tube 24. Thus, the shim plate 450provides a coarse control where the fluid flow rate of 2,000 to 8,000ml/hr in the wide open position may be quickly adjusted to a fluid flowrate of 250 ml/hr when the shim plate 450 is moved into the engagedposition. As another example, the fluid flow rate may be quicklyadjusted to a fully blocked flow rate of 0 ml/hr (e.g., quickocclusion), or any other desired fluid flow rate between 250 ml/hr and 0ml/hr (e.g., 50 ml/hr, 125 ml/hr), when the shim plate 450 is moved intothe fully engaged position. Thus, the shim plate 450 may be configuredas a linearly adjusting flow switch (e.g., dimmer switch), for example,where the flow rate linearly adjusts down from a wide open flow rate toa final coarse flow rate (e.g., 250 ml/hr), or even to a fully blockedflow rate (e.g., 0 ml/hr).

The combination of the shim plate 450 and the roller 130 provides forboth coarse and fine control of the fluid flow in tube 24. For example,with both the shim plate 450 and the roller 130 in their respective wideopen positions, the shim plate 450 may be moved towards or to the fullyengaged position, thus quickly adjusting the fluid flow rate anywherefrom the wide open rate of 2,000 to 8,000 ml/hr down to 250 ml/hr, oreven to a fully blocked flow (e.g., quick occlusion). For an adjustedfluid flow rate that is not fully occluded, the roller 130 may then bemoved within the housing 405 to increasingly impinge further upon tube24 in a more gradual manner, providing a finer and more preciseadjustment of the fluid flow rate. For example, the roller 130 may bemoved from its wide open position near one end of the housing 405 inwhich the fluid flow rate is 250 ml/hr to a fully impinging positiontowards the opposite end of the housing 405 in which the fluid flow rateis 0 ml/hr (e.g., fully blocked). The length of travel of the roller 130between the two positions allows for granular and precise changes influid flow rate via the roller 130 with the shim plate 450 partially orfully engaged. For an adjusted fluid flow rate that is fully occludedafter full engagement of the shim plate 450, movement of the roller 130may not be needed nor provide further flow rate adjustment.

The precision roller clamp assembly 400 may be configured so that theshim plate 450 is automatically moved to a particular engaged positionwhen the roller 130 is moved from its wide open position to an initialcontrol position (e.g., where the roller 130 initially begins to impingethe tube 24). In this manner, a user (e.g., healthcare provider,patient) or an adjustment device only needs to touch and adjust theroller 130.

The housing 405 may include a guide channel 460 disposed within eachside wall 410. The guide channel 460 may have one or more retentionsections 462 configured to receive a retention pin 464 coupled to thetube engagement wall 454. For example, when the retention pin 464 isdisposed within an opposing pair of retention sections 462, the shimplate 450 may be held in place within the housing 405. A pushing orpulling force on the grip member 452 may overcome the retention force ofthe retention pin 464 engaged with the retention sections 462, allowingthe tube engagement wall 454 to move further into or out of the housing405. Also, the shim plate 450 may be configured, via the angle of theshim plate 450 and the retention sections 462, to prevent slippage ofthe roller 130 in order to minimize or prevent flow rate drifting.Accordingly, the roller 130 may only slip forwards to further close theclamping gap, but may be prevented from slipping backwards, thuspreventing further opening the clamping gap.

With reference to FIG. 16 , a method 500 of operating a precision rollerclamp assembly is provided. In step 510, tubing (e.g., IV tubing) isplaced or disposed in a precision roller clamp assembly 100, 200, 300,400. For example, tube 24 may be inserted into housing 105, 205, 305,405 with both a slide/shim plate 150, 250, 350, 450 and a roller 130 inwide open positions (e.g., not contacting or impinging the tube 24).

The slide/shim plate 150, 250, 350, 450 is moved to engage and impingethe tube 24 in step 520. For example, the slide plate 150, 250, 350 maybe moved on a front wall 140 end of the housing 105, 205, 305orthogonally to and towards the tube 24 to cause a compression force tosqueeze the contacted portion of the tube 24, thus causing the fluidflow rate in the tube 24 to rapidly change to a lower flow rate (e.g.,from a wide open rate of 2,000 to 8,000 ml/hr down to 250 ml/hr, or evento a fully blocked flow or quick occlusion). As another example, theshim plate 450 may be moved further into the housing 405 in parallelwith the tube 24, causing a compression force to squeeze the contactedportion of the tube 24 and causing the fluid flow rate in the tube 24 torapidly change to a lower flow rate. With the use of the shim plate 450,the shim plate 450 is moved so that a retention pin 464 is received by apair of retention sections 462 disposed in side walls 410 of the housing405, in step 530.

In step 540, the roller 130 may be moved to engage and impinge the tube24. For example, the roller 130 may be moved from the front wall 140,440 end of the housing 105, 205, 305, 405 towards the opposite end ofthe housing 105, 205, 305, 405 so that a narrowing between a guide wall112, 412 and the roller 130 causes the roller to compress or squeeze thecontacted portion of the tube 24, thus causing the fluid flow rate inthe tube 24 to slowly change to a lower or blocked flow rate (e.g., from250 ml/hr to 0 ml/hr).

The slide/shim plate 150, 250, 350, 450 and the roller 130 may beadjusted independently to each other or in combination with each otherto achieve the desired fluid flow rate in the tube 24. For example, oneof the slide/shim plate 150, 250, 350, 450 and the roller 130 may beadjusted to impinge upon the tube 24 while the other of the slide/shimplate 150, 250, 350, 450 and the roller 130 remain in the wide openposition. As another example, adjustment of the roller 130 mayautomatically adjust the slide/shim plate 150, 250, 350, 450. Thus, anycombination of coarse and fine adjustments may be made to the fluid flowrate in the tube 24.

It is understood that any specific order or hierarchy of blocks in themethods of processes disclosed is an illustration of example approaches.Based upon design or implementation preferences, it is understood thatthe specific order or hierarchy of blocks in the processes may berearranged, or that all illustrated blocks be performed. In someimplementations, any of the blocks may be performed simultaneously.

The present disclosure is provided to enable any person skilled in theart to practice the various aspects described herein. The disclosureprovides various examples of the subject technology, and the subjecttechnology is not limited to these examples. Various modifications tothese aspects will be readily apparent to those skilled in the art, andthe generic principles defined herein may be applied to other aspects.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically so stated, but rather “one or more.”Unless specifically stated otherwise, the term “some” refers to one ormore. Pronouns in the masculine (e.g., his) include the feminine andneuter gender (e.g., her and its) and vice versa. Headings andsubheadings, if any, are used for convenience only and do not limit theinvention.

The word “exemplary” is used herein to mean “serving as an example orillustration.” Any aspect or design described herein as “exemplary” isnot necessarily to be construed as preferred or advantageous over otheraspects or designs. In one aspect, various alternative configurationsand operations described herein may be considered to be at leastequivalent.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “or” to separate any of the items, modifies thelist as a whole, rather than each item of the list. The phrase “at leastone of” does not require selection of at least one item; rather, thephrase allows a meaning that includes at least one of any one of theitems, and/or at least one of any combination of the items, and/or atleast one of each of the items. By way of example, the phrase “at leastone of A, B, or C” may refer to: only A, only B, or only C; or anycombination of A, B, and C.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations.An aspect may provide one or more examples. A phrase such as an aspectmay refer to one or more aspects and vice versa. A phrase such as an“embodiment” does not imply that such embodiment is essential to thesubject technology or that such embodiment applies to all configurationsof the subject technology. A disclosure relating to an embodiment mayapply to all embodiments, or one or more embodiments. An embodiment mayprovide one or more examples. A phrase such an embodiment may refer toone or more embodiments and vice versa. A phrase such as a“configuration” does not imply that such configuration is essential tothe subject technology or that such configuration applies to allconfigurations of the subject technology. A disclosure relating to aconfiguration may apply to all configurations, or one or moreconfigurations. A configuration may provide one or more examples. Aphrase such a configuration may refer to one or more configurations andvice versa.

In one aspect, unless otherwise stated, all measurements, values,ratings, positions, magnitudes, sizes, and other specifications that areset forth in this specification, including in the claims that follow,are approximate, not exact. In one aspect, they are intended to have areasonable range that is consistent with the functions to which theyrelate and with what is customary in the art to which they pertain.

It is understood that the specific order or hierarchy of steps,operations or processes disclosed is an illustration of exemplaryapproaches. Based upon design preferences, it is understood that thespecific order or hierarchy of steps, operations or processes may berearranged. Some of the steps, operations or processes may be performedsimultaneously. Some or all of the steps, operations, or processes maybe performed automatically, without the intervention of a user. Theaccompanying method claims, if any, present elements of the varioussteps, operations or processes in a sample order, and are not meant tobe limited to the specific order or hierarchy presented.

All structural and functional equivalents to the elements of the variousaspects described throughout this disclosure that are known or latercome to be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe claims. Moreover, nothing disclosed herein is intended to bededicated to the public regardless of whether such disclosure isexplicitly recited in the claims. No claim element is to be construedunder the provisions of 35 U.S.C. § 112 (f) unless the element isexpressly recited using the phrase “means for” or, in the case of amethod claim, the element is recited using the phrase “step for.”Furthermore, to the extent that the term “include,” “have,” or the likeis used, such term is intended to be inclusive in a manner similar tothe term “comprise” as “comprise” is interpreted when employed as atransitional word in a claim.

The Title, Background, Summary, Brief Description of the Drawings andAbstract of the disclosure are hereby incorporated into the disclosureand are provided as illustrative examples of the disclosure, not asrestrictive descriptions. It is submitted with the understanding thatthey will not be used to limit the scope or meaning of the claims. Inaddition, in the Detailed Description, it can be seen that thedescription provides illustrative examples and the various features aregrouped together in various embodiments for the purpose of streamliningthe disclosure. This method of disclosure is not to be interpreted asreflecting an intention that the claimed subject matter requires morefeatures than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed configuration or operation. The followingclaims are hereby incorporated into the Detailed Description, with eachclaim standing on its own as a separately claimed subject matter.

The claims are not intended to be limited to the aspects describedherein, but are to be accorded the full scope consistent with thelanguage claims and to encompass all legal equivalents. Notwithstanding,none of the claims are intended to embrace subject matter that fails tosatisfy the requirement of 35 U.S.C. § 101, 102, or 103, nor should theybe interpreted in such a way.

What is claimed is:
 1. A roller clamp assembly comprising: a housingconfigured to receive a flexible tube, the housing comprising: twoopposing side walls; a front wall disposed at one end of the side walls;and a guide wall disposed between the side walls; a roller wheel movablydisposed in the housing, the roller wheel configured to move along alongitudinal axis of the housing, wherein spacing between the guide walland the roller wheel decreases over a length of the guide wall; and aplate configured to slideably engage with a portion of the housing, theplate comprising: a grip member; and a tube engagement member configuredto compress the flexible tube a varying amount as the plate is moved inrelation to the housing.
 2. The roller clamp assembly of claim 1,wherein sliding of the roller wheel in a direction of lesser spacingbetween the guide wall and the roller wheel causes the roller wheel toimpinge on the flexible tube to a gradually increasing extent, whereinthe increased impingement of the roller wheel on the flexible tube isconfigured to reduce a fluid flow rate through the flexible tube.
 3. Theroller clamp assembly of claim 1, wherein the front wall comprises twogrooves, each groove configured to slidingly receive a portion of theplate.
 4. The roller clamp assembly of claim 1, wherein the tubeengagement member is a channel centrally disposed on a leading edge ofthe plate.
 5. The roller clamp assembly of claim 4, wherein the channelcomprises a first portion having a first uniform width, a second portionhaving a varying width that decreases as a distance from the leadingedge of the plate increases, and a third portion having a second uniformwidth that is less than the first uniform width.
 6. The roller clampassembly of claim 4, wherein the channel comprises a first portionhaving a varying width that decreases as a distance from the leadingedge of the plate increases and a second portion having a uniform width.7. The roller clamp assembly of claim 4, wherein at least a portion ofthe channel comprises a linearly decreasing width as a distance from theleading edge of the plate increases.
 8. The roller clamp assembly ofclaim 1, wherein the tube engagement member is a channel disposed in anoffset from central position on a leading edge of the plate.
 9. Theroller clamp assembly of claim 8, wherein the channel comprises a firstportion having a varying width that decreases as a distance from theleading edge of the plate increases and a second portion having auniform width.
 10. The roller clamp assembly of claim 8, wherein thechannel comprises a first straight side extending from the leading edgeof the plate and a second opposing side having an angled portionextending from the leading edge of the plate.
 11. The roller clampassembly of claim 1, wherein the housing has an open-ended boxlikeconstruction.
 12. The roller clamp assembly of claim 1, wherein theplate is configured to provide a first amount of compression to theflexible tube and the roller wheel is configured to provide a secondamount of compression to the flexible tube.
 13. The roller clampassembly of claim 12, wherein the first amount of compression comprisesa rapid impingement to the flexible tube and the second amount ofcompression comprises a gradual impingement to the flexible tube. 14.The roller clamp assembly of claim 1, wherein each side wall comprises aguide channel disposed on a longitudinal axis of the housing, each guidechannel having one or more retention sections.
 15. The roller clampassembly of claim 14, wherein the tube engagement member comprises anengagement wall having a varying thickness.
 16. The roller clampassembly of claim 15, further comprising a retention pin coupled to theengagement wall, the retention pin configured to be received by a pairof opposing retention sections.
 17. The roller clamp assembly of claim15, wherein the engagement wall is configured to be slidably moveablealong the guide wall to provide a shim force on the flexible tube. 18.An infusion set comprising: an infusion component; a flexible tube; anda roller clamp assembly, the roller clamp assembly comprising: a housingconfigured to receive a flexible tube, the housing comprising: twoopposing side walls; a front wall disposed at one end of the side walls;and a guide wall disposed between the side walls; a roller wheel movablydisposed in the housing, the roller wheel configured to move along alongitudinal axis of the housing, wherein spacing between the guide walland the roller wheel decreases over a length of the guide wall; and aplate configured to slideably engage with a portion of the housing, theplate comprising: a grip member; and a tube engagement member configuredto compress the flexible tube a varying amount as the plate is moved inrelation to the housing, wherein an increased impingement of the rollerwheel on the flexible tube is configured to reduce a fluid flow ratethrough the flexible tube.
 19. A method of adjusting a fluid flow ratethrough a flexible tube coupled to a fluid source, the methodcomprising: inserting the flexible tube through the housing of theroller clamp assembly of claim 1; sliding the plate relative to thehousing to compress the flexible tubing with a first impingement toproduce a coarse adjustment that causes a rapid decrease in the fluidflow rate through the flexible tube; and rolling the roller wheelrelative to the housing to compress the flexible tubing with a secondimpingement to produce a fine adjustment that causes a further gradualdecrease in the fluid flow rate through the flexible tube.
 20. Themethod according to claim 19, wherein the sliding the plate comprisesone of: sliding the plate in grooves on an exterior wall of the housing,wherein the plate moves orthogonally to the flexible tube; and slidingthe plate along an interior wall of the housing, wherein the plate movesin parallel to the flexible tube.